Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. While some GDocP standards are codified by various competent authorities, others are not but are considered cGMP (with emphasis on the "c", or "current"). Some competent authorities release or adopt guidelines, and they may include non-codified GDocP expectations. While not law, authorities will inspect against these guidelines and cGMP expectations in addition to the legal requirements and make comments or observations if departures are seen. In the past years, the application of GDocP is also expanding to cosmetic industry, excipient and ingredient manufacturers.
Where appropriate, the reason for alteration must be noted[1]: ¶4.9 [2][3][7]
Controls exist to prevent the inadvertent use of superseded documents[3][9]
Electronic versions can only be modified by authorized personnel[2]
A history (audit trail) must be maintained of changes and deletions to electronic versions[2][4][5]
Supporting documents can be added to the original document as an attachment for clarification or recording data. Attachments should be referenced at least once within the original document. Ideally, each page of the attachment is clearly identified (i.e. labeled as "Attachment X", "Page X of X", signed and dated by person who attached it, etc.)
GDocP interpretationedit
From the regulatory guidance above, additional expectations or allowances can be inferred by extension. Among these are:
Prohibition against removing pages[10] – the removal of a page would obscure the data that were present, so this is not permissible.
Page numbering[10] – the addition of page numbers, particularly in "Page x of y" format, allows a reviewer to ensure that there are no missing pages.
Stamped signatures in Asia – the culture of certain Asian countries, and the controls they employ, are such that their use of a stamp in lieu of handwritten signatures has been accepted.
Date and time formats[10] – dates may be written in a variety of formats that can be confusing if read by personnel with a different cultural background. In the context where different cultures interact, a date such as "07-05-10" can have numerous different meanings and therefore, by GDocP standards above, violates the requirement for being clear.
Transcription[10] – a transcription of data, where the original document is not retained, effectively obscures the original data and would be prohibited. Transcription may be helpful where the original is of poor quality writing or is physically damaged, but it should be clearly marked as a transcription and the original retained nevertheless.
Scrap paper, Post-it notes – intentionally recording raw data on non-official records is a set-up for transcription and is therefore prohibited.
Avoiding asterisks as part of the notation of a hand-change – where insufficient white space permits a fully notated hand change, a common practice is to use an asterisk (or other mark) near the correction, and elsewhere record the same mark and the notation. The risk is that additional changes are made by another person who uses the same mark, and now the notation can be interpreted to apply to all changes with the mark. Some will therefore advise against the use of the asterisk.[10] Others will accept it, if the notation clearly includes the number of changes that it applies to, such as, "* Three entries changed above due to entry errors. KAM 13-Jan-2011". There are no known instances of an agency rejecting such a notation.
Enforcementedit
The competent authorities are empowered to inspect establishments to enforce the law and the interpretations of the law (e.g., the content of guidance documents and the cGMPs).
Departures from GDocP that involved the regulator have included: documentation not contemporaneous,[11][12] use of ditto marks,[13] signature stamps.,[14][15] obscured original data,[16] Use of pencil,[16] inaccurate records,[16] and not dating changes.[17]
^ abcdefghijklmn"Chapter 4. Documentation" (PDF). Volume 4. Good Manufacturing Practice: Medicinal Products for Human and Veterinary Use (Report). Brussels: European Commission, Health and Consumer Directorate-General. 2010. (PDF) from the original on 19 July 2022. Retrieved 15 October 2022.
^ abcdefg This article incorporates public domain material from "Guidance for Industry - COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS". U.S. Food and Drug Administration. April 1999. from the original on 24 September 2020. Retrieved 15 October 2022.
^ abcdefghiWHO Expert Committee on Specifications for Pharmaceutical Preparations (2011). "Annex 3. WHO good manufacturing practices for pharmaceutical products: main principles" (PDF). Forty-fifth Report(PDF) (Technical report). WHO Technical Report Series. World Health Organization. 961. (PDF) from the original on 1 September 2022.
^ abcdef"ICH Official web site : ICH". www.ich.org. Retrieved 7 March 2023.
^ ab"Part I, Chapter 6 Quality Control" (pdf), The rules governing medicinal products in the European Union, vol. 4, EU Guidelines to Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use., 1 June 2006, p. 3
^ abcde"Code of Federal Regulations Title 21". U.S. Food and Drug Administration. 21CFR211 Subpart J. Retrieved 7 March 2023.
^US FDA. "HUMAN DRUG CGMP NOTES" (Volume 8, Number 3) September, 2000
^ abcJapan MHLW. Ministerial Ordinance No. 169, 2004, "Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-Vitro Diagnostic Reagents" (Chapter 2, Section 2, Article 8, Paragraphs 2 and 4) 22 July 2011 at the Wayback Machine – Accessed 7 January 2011
^ abcdeHurd, Don (2010), Good Documentation Practices(PDF), et al., Premier Validation, pp. 11, 17, 30, 39, ISBN978-1-908084-00-2, (PDF) from the original on 13 November 2012
^US FDA. Form FDA 483 issued to L. Perrigo Co., dated 11/07/2008. Observation #9A
May 08, 2024
good, documentation, practice, recommended, abbreviate, gdocp, distinguish, from, good, distribution, practice, also, abbreviated, term, pharmaceutical, medical, device, industries, describe, standards, which, documents, created, maintained, while, some, gdocp. Good documentation practice recommended to abbreviate as GDocP to distinguish from good distribution practice also abbreviated GDP is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained While some GDocP standards are codified by various competent authorities others are not but are considered cGMP with emphasis on the c or current Some competent authorities release or adopt guidelines and they may include non codified GDocP expectations While not law authorities will inspect against these guidelines and cGMP expectations in addition to the legal requirements and make comments or observations if departures are seen In the past years the application of GDocP is also expanding to cosmetic industry excipient and ingredient manufacturers Contents 1 GDocP standards 1 1 Documentation creation 1 2 Document approval 1 3 Handwritten entries 1 4 Copies of documents 1 5 Document maintenance 1 6 Document modification 2 GDocP interpretation 3 Enforcement 4 See also 5 ReferencesGDocP standards editDocumentation creation edit Contemporaneous with the event they describe 1 4 8 2 3 4 Not handwritten except for handwritten entries thereon 1 4 6 When electronically produced the documentation must be checked for accuracy 1 page needed Free from errors 2 5 For some types of data it is recommended that records are in a format that permits trend evaluation 6 Document approval edit Approved signed and dated by appropriate authorized personnel 1 4 3 4 7 Handwritten entries edit Adequate space is provided for expected handwritten entries 1 4 6 3 Handwritten entries are in indelible ink 1 4 6 3 4 Errors i e misspelling illegible entries etc are corrected and reason is documented Critical entries must be independently checked SPV or second person verified 1 page needed 7 No spaces for handwritten entries are left blank if unused they are crossed out or N A or similar text entered Ditto marks or continuation lines are not acceptable 8 Correction fluid are not allowed to be used in correcting errors A stamp in lieu of a handwritten signature is not acceptable Copies of documents edit Clear legible 1 page needed 3 9 Errors are not introduced 1 4 2 3 7 Document maintenance edit Regularly reviewed and kept current 1 4 5 5 Retained and available for appropriate duration 1 4 12 5 6 7 9 Electronic document management systems are validated 5 Electronic records are backed up 5 Document modification edit Handwritten modifications are signed and dated 1 4 9 2 3 4 Altered text is not obscured e g no correction fluid 1 4 9 2 3 4 Where appropriate the reason for alteration must be noted 1 4 9 2 3 7 Controls exist to prevent the inadvertent use of superseded documents 3 9 Electronic versions can only be modified by authorized personnel 2 A history audit trail must be maintained of changes and deletions to electronic versions 2 4 5 Supporting documents can be added to the original document as an attachment for clarification or recording data Attachments should be referenced at least once within the original document Ideally each page of the attachment is clearly identified i e labeled as Attachment X Page X of X signed and dated by person who attached it etc GDocP interpretation editFrom the regulatory guidance above additional expectations or allowances can be inferred by extension Among these are Prohibition against removing pages 10 the removal of a page would obscure the data that were present so this is not permissible Page numbering 10 the addition of page numbers particularly in Page x of y format allows a reviewer to ensure that there are no missing pages Stamped signatures in Asia the culture of certain Asian countries and the controls they employ are such that their use of a stamp in lieu of handwritten signatures has been accepted Date and time formats 10 dates may be written in a variety of formats that can be confusing if read by personnel with a different cultural background In the context where different cultures interact a date such as 07 05 10 can have numerous different meanings and therefore by GDocP standards above violates the requirement for being clear Transcription 10 a transcription of data where the original document is not retained effectively obscures the original data and would be prohibited Transcription may be helpful where the original is of poor quality writing or is physically damaged but it should be clearly marked as a transcription and the original retained nevertheless Scrap paper Post it notes intentionally recording raw data on non official records is a set up for transcription and is therefore prohibited Avoiding asterisks as part of the notation of a hand change where insufficient white space permits a fully notated hand change a common practice is to use an asterisk or other mark near the correction and elsewhere record the same mark and the notation The risk is that additional changes are made by another person who uses the same mark and now the notation can be interpreted to apply to all changes with the mark Some will therefore advise against the use of the asterisk 10 Others will accept it if the notation clearly includes the number of changes that it applies to such as Three entries changed above due to entry errors KAM 13 Jan 2011 There are no known instances of an agency rejecting such a notation Enforcement editThe competent authorities are empowered to inspect establishments to enforce the law and the interpretations of the law e g the content of guidance documents and the cGMPs Departures from GDocP that involved the regulator have included documentation not contemporaneous 11 12 use of ditto marks 13 signature stamps 14 15 obscured original data 16 Use of pencil 16 inaccurate records 16 and not dating changes 17 See also editBest practice Good manufacturing practice Site Master FileReferences edit a b c d e f g h i j k l m n Chapter 4 Documentation PDF Volume 4 Good Manufacturing Practice Medicinal Products for Human and Veterinary Use Report Brussels European Commission Health and Consumer Directorate General 2010 Archived PDF from the original on 19 July 2022 Retrieved 15 October 2022 a b c d e f g nbsp This article incorporates public domain material from Guidance for Industry COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS U S Food and Drug Administration April 1999 Archived from the original on 24 September 2020 Retrieved 15 October 2022 a b c d e f g h i WHO Expert Committee on Specifications for Pharmaceutical Preparations 2011 Annex 3 WHO good manufacturing practices for pharmaceutical products main principles PDF Forty fifth Report PDF Technical report WHO Technical Report Series World Health Organization 961 Archived PDF from the original on 1 September 2022 a b c d e f ICH Official web site ICH www ich org Retrieved 7 March 2023 a b c d e f European Commission Directive 2003 94 EC Article 9 a b Part I Chapter 6 Quality Control pdf The rules governing medicinal products in the European Union vol 4 EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use 1 June 2006 p 3 a b c d e Code of Federal Regulations Title 21 U S Food and Drug Administration 21CFR211 Subpart J Retrieved 7 March 2023 US FDA HUMAN DRUG CGMP NOTES Volume 8 Number 3 September 2000 a b c Japan MHLW Ministerial Ordinance No 169 2004 Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In Vitro Diagnostic Reagents Chapter 2 Section 2 Article 8 Paragraphs 2 and 4 Archived 22 July 2011 at the Wayback Machine Accessed 7 January 2011 a b c d e Hurd Don 2010 Good Documentation Practices PDF et al Premier Validation pp 11 17 30 39 ISBN 978 1 908084 00 2 archived PDF from the original on 13 November 2012 US FDA Warning Letter UCM271708 Observation 1 Accessed 27 June 2013 Caraco Pharmaceutical Laboratories Ltd Response to the FDA s May 12 2009 483 Observation 14a Accessed 1 June 2011 US FDA Warning Letter FLA 99 29 US FDA Warning Letter UCM075960 Accessed 4 February 2010 US FDA Warning Letter UCM066113 a b c US FDA Warning Letter UCM069041 US FDA Form FDA 483 issued to L Perrigo Co dated 11 07 2008 Observation 9A Retrieved from https en wikipedia org w index php title Good documentation practice amp oldid 1221984405, wikipedia, wiki, book, books, library,
